▎WuXi AppTec Content Team Report

The official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration shows that the investigational new drug HS-20106 injection, submitted by Keros Therapeutics, has received implied permission for clinical trials.Intended to be developed for the treatment of cytopenia caused by various reasons. Public information shows,HS-20106（KER-050) is an "engineered ligand trap" being developed for the treatment of cytopenias (including anemia and thrombocytopenia) in patients with myelodysplastic syndromes (MDS) and myelofibrosis.Hansoh Pharma has secured the exclusive rights to the product in mainland China, Hong Kong, and Macao through a nearly $200 million collaboration.

Screenshot source:CDE Official Website

Hematopoiesis is the process of blood cell production in the bone marrow. When blood cells mature appropriately, they leave the bone marrow and enter circulation. Ineffective hematopoiesis, where immature blood cells fail to properly develop into mature cells, can lead to low levels of circulating red blood cells (anemia), white blood cells (neutropenia), or platelets (thrombocytopenia).

Public information shows,KER-050 is an "engineered ligand trap", composed of the ligand-binding region of a modified TGF-β receptor (i.e., activin receptor type IIA) fused with the Fc region of a human antibody.According toKeros Therapeutics, Inc. Official Website Information,KER-050 belongs toActivin Receptor IIA (ActRIIA) fusion protein, designed to selectively inhibit TGF-β ligands, including activin A。Activin A, a member of the TGF-β superfamily, is associated with bone loss, metastasis, and increased bone marrow damage when elevated.。KER-050Designed toCombines with and inhibits activin A, with the potential to improve bone marrow and restore normal hematopoiesis by targeting multiple cell lineages.。

In December 2021, Hansoh Pharma and Keros Therapeutics jointly announced a strategic collaboration granting Hansoh exclusive rights to Keros’ lead drug, KER-050, in China. Under the agreement, Hansoh Pharma will obtain exclusive rights for the development, manufacturing, and commercialization of the product in mainland China, Hong Kong, and Macao; in return, Keros will receive an upfront payment.2$000 million, and is expected to receive development and commercial milestone paymentsUp to $170.5 million, as well as tiered royalties on net product sales.

Based on the data from the completed Phase 1 clinical trial and multiple preclinical studies,KerosCompanyBelieve KER-050Has the potential to play a role in cell differentiation and maturation during hematopoiesis., increase the production of red blood cells and platelets while improving bone health and quality.According toClinicalTrialsWebsite,KER-050 is being developed for the treatment of myelodysplastic syndromes (MDS) and myelofibrosis.（MF）The patient, relevant clinical trials have all progressed to Phase 2 clinical stage.。

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Oct 16, 2023. From https://www.cde.org.cn/main/xxgk/listpage/2f78f372d351c6851af7431c7710a731

[2] Hansoh Pharma Announces Strategic Collaboration with Keros Therapeutics for Exclusive Rights to KER-050 in China. Retrieved Dec 14, 2021. From https://mp.weixin.qq.com/s/Dh-o_b0m9Erv32qsatuAvw

[4]KER-050 for Treatment of Ineffective Hematopoiesis . From https://www.kerostx.com/hematology-franchise/ker050